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From NCE to NICE: the role of Pharmacoeconomics

What Is the Price Benchmark to Replace Average Wholesale Price (AWP)?

NICE announces development of further Quality Standards

Avastin patient access scheme too complicated, says NICE

Comparative Effectiveness—of What? Evaluating Strategies to Improve Population Health

Market access and patient access schemes

Market access: Risk sharing and alternative pricing schemes

US breast cancer drug decision 'marks start of death panels'

Medical Affairs at the centre of life sciences innovation

Rising Burden of Diseases Drives the Pharmaceutical Industry in East Africa Says Frost & Sullivan

Is Health Care Special?

CRD international register of ongoing systematic reviews

Hospitals Should Plan Now for Value-Based Purchasing, Which May Be a Game-Changer

Comparative Effectiveness Research

Health care and revenue competition in Britain

Literature Review Examines Value of Managed Care Pharmacy Tools

Compelling Evidence Regarding Effectiveness Of Managed Care Pharmacy Tools In Achieving Intended Outcomes

IBM, Aetna roll out cloud-based clinical decision support system

Health Economics Spending Increases 45% in Emerging Markets, 8% in the US

Health Secretary Andrew Lansley announces new NHS ‘quality standards’

PharmaNet, Abacus ally on ‘real world' research

The Impact of Employer Health and Productivity Management Practices

NICE ‘yes’ in 80% of treatment appraisals

Providers Have Won Majority of RAC Claims Denials They Have Appealed

Study examines UK’s NICE as model producer of HTA

Health Secretary Andrew Lansley announces new NHS ‘quality standards’

Government kicks off consultation on outcomes framework

Will More Insurers Control Health Care Costs Better?

Will Janssen-Cilag's ADHD YouTube Video Go Viral and Win an Award?

Reimbursement by Distributors

Growing application of pharmacoeconomics and outcomes research in health-care decision-making in the Asia-Pacific region.Yang BM, Lee K. Value Health. 2009 Nov-Dec;12 Suppl 3:S1-2.

Value-based Pricing to be Introduced to the UK Pharma Industry by 2014

Disclosing Industry Relationships — Toward an Improved Federal Research Policy

Pharmacoeconomics: friend or foe?

NHS reform – a bold vision or a dangerous gamble?

GSK's Coverup of Avandia's Heart Risk Data: Is This How the Entire Industry Views Its Repsonsibility to Patients?

Oncology drug price cuts announced in Italy related to perfomance based schemes

US And European Prices Aren’t So Different After All

Grand challenges in pharmacoeconomics and health outcomes

White Paper: An Economic Assessment of the Relationship between Price Regulation and Incentives to Innovate in the Pharmaceutical Industry

Clarifying Sources of Geographic Differences in Medicare Spending

Is The Impact of Comparative Effectiveness Reports Being Evaluated? by Rebecca Singer Cohen Rebecca Singer Cohen View Author Bio and Bryan Luce

Biosimilars’ Price Dynamic in Europe, Dr Matthias Liefner of Simon Kucher and Partners.

AQoL Website - Centre for Health Economics, Monash University

“How To Negotiate Salary”, a submitted article by Bill Cebak - Founder / Headhunter Global HEOR, Market Access and Medical Communications Practice since 1993

AMCP eDossier System: A Partnership that Works! AMCP News June 2010

Dartmouth Atlas: A Response to Its Researchers

D2 Review : APHA and AMCP introduce MTM Connections a fantastic site for new professional opportunities

Including Pregnant Women in Clinical Research Called ‘Imperative’

Selecting Quality and Resource Use Measures A Decision Guide for Community Quality Collaboratives

Spending More on Drugs Doesn’t Mean Spending Less On Other Care

Trendspotter: Consumer Survey Shows Opposition to Evidence-Based Medicine

Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Former CMS Official’s Off-Label Work May Help Reform Law’s CER Center

Patient-reported outcome measures in the NHS: new methods for analysing and reporting EQ-5D data

Integrated Health Ecosystem Key to Creating Better Health Outcomes and Managing Costs for Employers and Health Plans

The Health Care Economy: New Questions About Costs, Quality And Care

The Amazing Maze of US Health Care

Universal Healthcare Myths | New Health Care Bill Facts

Pricing, profits and pharmacoeconomics - for whose benefit?

Symposium on Research Methods for Clinical and Comparative Effectiveness Studies – Part II

France, Italy announce drug pricing cuts

"AMCP Launches Health Care Reform Implementation Web Page"

2010 Lecture: US Health Care Reform

Biosimilars: Issues Overview

AZ's fixed-price deal on Iressa gets NICE nod

Transforming Trial Results Into Practice Change: The Final Translational Hurdle

Obama’s New Health Rationer-in-Chief

NICE to move to value-based pricing?

Reimbursement of New High Cost Drugs – Deal or No Deal! by:Michael Barry MD, PhD, FRCPI, 2009-2010 ISPOR President and Clinical Director National Centre for Pharmacoeconomics, St. James’s Hospital, Dublin, Ireland

UK Government Wants To Revamp Drug Watch Dog NICE

New FDA Campaign Targets Detailing, Trade Shows

Advances in technology highlight need of Pharmacoeconomics in managing healthcare: Dr Rajesh Balakrishnan

RFP for 2011 IBI/NBCH Health & Productivity Forum

Funny Pharmacy Videos. These are Hysterical! Particularly "The PharmG's - Boom Intervention" Rap

Job Title Company

BIOSTATISTICIAN III - Duke Clinical Research Institute DCRI

Research Health Economist RTI Health Solutions

VP Research & Analysis Express Scripts

Post-Doctoral Fellowship / Faculty-track Internship in Health Technology Assessment and Pharmacoeconomics McMaster University

DIRECTOR, HEALTH ECONOMICS & MARKET ACCESS Medaxial

The Trials and Tribulations of Evidence Based Medicine By Vanessa Webb

All health care systems have to be cost effective and therefore make financial decisions to balance the books - but let us understand that this is the driving force for evidenced based medicine. There are gains by understanding evidenced based medicine: we are able to evaluate risks as well as positive outcomes.

A screening change based on evidence

The U.S. Preventive Services Task Force gained considerable attention with the release of its new recommendations against the current standard practices of breast cancer screening. (Source: Amy Abernathy, NewsObserver.com, Nov. 2009)

Academy of Managed Care Pharmacy (AMCP)

YouTube Video where Academy of Managed Care Pharmacy (AMCP) discusses issues that health plans need to consider to prepare for the eventual arrival of follow-on biologics.

AHRQ 2009 Annual Conference

To help advance its goal of improving health care for all Americans, the Agency for Healthcare Research and Quality (AHRQ) held its third annual conference on September 13-16, 2009, in Bethesda, MD. This conference was designed to showcase the best of the Agency's research and provide examples of how that research is being implemented at all levels in health care delivery. Entitled "Promoting Quality... Partnering for Change," the conference featured presentations in seven major themes. Click for some relevant presentations.

AMCP eDossier System

The AMCP eDossier System is a centralized, secure, web-based platform, that provides qualified health care decision makers the opportunity to easily access, review, and evaluate research to make informed, evidence-based decisions.

AMCP Guide to Pharmaceutical Payment Methods — 2009 Update

This is an update of the October 2007 AMCP Guide to Pharmaceutical Payment Methods¹ which was created by the Academy of Managed Care Pharmacy Task Force on Pharmaceutical Payment Methods, in conjunction with the consulting firm of Tag & Associates, Inc. The update incorporates revisions by Tag & Associates, Inc. (Howard Tag, JD, and Elan Rubinstein, PharmD, MPH), Alexandria, VA.

Application of Healthcare Intervention Economic Evaluation

Advisory Panel report from ISPOR Working Group

Assessing Comparative Effectiveness Research in the US

Assessing Comparative Effectiveness Research in the US. (Source: Applied Health Economics & Health Policy: 1 December 2009 - Volume 7 - Issue 4 - pp 219-224)

Assessing the Need to Update Comparative Effectiveness Research Reviews

This site is frequently updated, but can be used to link to the most recent reports. (Source: AHRQ, Nov. 2009)

Association between primary care physicians' evidence-based medicine knowledge and quality of care

Association between PCP's EBM knowledge and quality of care found that physicians with higher total EBM knowledge correlated modestly with better quality of care, but this explained only a small portion in the variance of clinical performance. Results indicate that there might be a need to focus on teaching all the components of EBM rather than EBM microskills. (Source: International Journal for Quality in Health Care, Nov. 4. 2009, rev. Jan. 16, 2010)

Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics

Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics. (Source: Alfred B. Engelberg, J.D., Aaron S. Kesselheim, M.D., J.D., M.P.H., and Jerry Avorn, M.D., NEJM, October 2009)

Bayesian Statistics for Health Economics and Outcomes Research by O

Wonderful primer that makes the subject of bayesian statistics understandable, relevant, and interesting.

Bias, Credibility and Quality in Economic Evaluations

Advisory Panel Report from ISPOR

CEA in clinical trials

From ISPOR Task Force. Good white paper.

Characteristics of Published Comparative Effectiveness Studies of Medications

Article by Michael Hochman et al. looks at active-comparator trials and how they were less likely than trials with inactive controls to report positive results. (Source: JAMA, March 10, 2010)

Characteristics of Published Comparative Effectiveness Studies of Medications

Only 32% of medication studies published in top medical journals compared the effectiveness of existing treatments, and active-comparator trials were less likely than trials with inactive controls to report positive results. (Source: Michael Hochman, MD; Danny McCormick, MD, MPH, JAMA, 2010;303(10):951-958)

Comparative Effectiveness News and presentations from the Eisenberg Conference Series 2009

This new issue of Comparative Effectiveness News features a set of white papers published in the September 22, 2009, issue of Medical Decision Making that will serve as the groundwork for an AHRQ Work Group charged with creating a new methods guide to focus on comparisons of diagnostic and prognostic tests for the Effective Health Care (EHC) Program. Also in this issue, the EHC Program process for updating the Comparative Effectiveness Reviews is summarized and a new feature, “The EHC Program Spotlight,” highlights the partners involved in the EHC Program. This issue introduces the Vanderbilt EPC at Vanderbilt University Medical Center.

Comparative Effectiveness Research (CER) and Pharmaceutical Companies (PPT Presentation)

Excellent overview of the use of CER and HEOR

Comparative Effectiveness Research HHS Website

The American Recovery and Reinvestment Act of 2009 created the Federal Coordinating Council for Comparative Effectiveness Research to coordinate comparative effectiveness research across the Federal government. The Council will specifically make recommendations for the $400 million allocated to the Office of the Secretary for CER. As part of its initial work, the Council is conducting Listening Sessions to hear public comments regarding comparative effectiveness research. Individuals interested in addressing the council may nominate themselves to deliver a three minute oral presentation before the council. Individuals and organizations may also submit written comments for the council’s consideration. The public may also attend the session, listen live via audio conference or watch the session online at www.hhs.gov/recovery.

Comparative Effectiveness Research: Relevance

Primer in AJHP by Schumock and Pickard: "Comparative Effectiveness Research: Relevance and Applications to Pharmacy" is a good basic overview. (Source: Glen T. Schumock and A. Simon Pickard, American Society of Health-System Pharmacists, Inc., 2009)

Comparative-Effectiveness Research Could Find New Uses for Drugs

Comparative-Effectiveness Research Could Find New Uses for Drugs. (Source: FDA News, Washington Drug Letter, Nov. 16, 2009)

Comparative-Effectiveness Research Could Find New Uses for Drugs

Comparative-effectiveness research (CER), provided for in congressional healthcare overhaul legislation, can fill in the gaps left by standard clinical trials by pinpointing subpopulations that respond to a particular drug, an expert says. (source: FDANews, Nov. 16, 2009)

David Eddy Delivers Controversial Lecture on the Future of EBM

Kent Bottles discusses David Eddy's history and recent speach in this posting. (Source: ICSI Health Care Blog, Nov. 30, 2009)

DEcIDE Research Network

The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care (EHC) Program is pleased to announce that reports from the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Research Network are now available on the EHC Program Web site.

Designing and Conducting CEA

Rather than focusing on theory, this practical book teaches students how to obtain data and then mold the data into a working analysis. All methods presented in the book adhere to the recommendations forwarded by the Panel on Cost-Effectiveness in Health and Medicine. Available from Amazon or Barnes&Noble.

Developing Nations Special Issue

This includes HTA, CEA, and discussion of barriers for Asia as a whole, Thailand, Taiwan, Uganda, Latin America and Caribbean, and low- and middle-income countries. (Source: Pharmaeconomics, Nov. 1. 2009)

Effective Health Care Program Update: CER Methods Symposium Proceedings

The Agency for Healthcare Research and Quality (AHRQ) is pleased to announce that proceeding from the 2009 Symposium on Research Methods for Clinical and Comparative Effectiveness Studies are now available on the Effective Health Care (EHC) Program Web site.

Effectiveness of an e-learning course in evidence-based medicine for foundation (internship) training

The goal was to evaluate the educational effectiveness of a clinically integrated e-learning course for teaching basic evidence-based medicine(EBM) among postgraduate medical trainees compared to a traditional lecture-based course of equivalent content.

EFFECTIVENESS OF CLINICAL GUIDELINES AS A MEANS FOR CHANGING BEHAVIOR

Clinical guidelines are designed with the major aim of improving quality of health care. This is reflected in the utilisation of evidence based practices and the employment of a series of models. The paper shall look at some of the intended impacts of clinical guidelines as a method of changing behaviour and the actual impacts caused by them.

Enabling Medication Management through Health Information Technology (Health IT)

Medication management is one of the major components of health care. It goes beyond prescribing. Bell's medication management model describes a framework for evaluating systems based on their functional capabilities. The model shows the 5 phases in medication management: select and prescribe, transmit, dispense, administer, and monitor; and 14 functional capabilities for medication management systems.

Evidence in Medicine: Correlation and Causation

First in a series of articles to discuss how to use evidence to arrive at reliable scientific conclusions? (Source Steven Novella, Science-Based Medicine, Nov. 18, 2009)

Evidence-Based Medicine Workbook

Based on workshops. Great resource

Evidence-based protocols

This unpublished opinion from the Second Circuit is instructive in showing that evidence-based protocols, e.g., clinical studies, may exceed what is required to show medical necessity, even under an abuse of discretion standard of review. (Source: Roy Harmon III, Health Plan Law, Nov. 18, 2009)

Evidenced-based Medicine Workbook

Evidence-based Medicine Workbook, Finding and applying the best research evidence to improve patient care. (Source: Glasziou, Del Mar, Salsbury, BMJ Books, September 2009)

Federal Coordinating Council for Comparative Effectiveness Research (Report to the President and the Congress)

June 30, 2009 77 page report with definition, criteria, infrastructure, strategic framework, priorities, etc.

From NCE to NICE: the role of pharmacoeconomics

Article by Hughes DA in Br J Clin Pharmacol. 2010;Sep 70(3):317-9. of the NHS, academia and the pharmaceutical industry is described, and projections on the increased use of risk-sharing and QALYs is discussed.

Future of Evidence-based Medicine, by David Eddy

Blog posting about November 2010 lecture questioning the value of EBM, by one of the formidable experts in the field. (Source: ICSI Health Care Blog)

Giving Teeth to Comparative-Effectiveness Research — The Oregon Experience

Experts believe that comparative-effectiveness research (CER) can substantially reduce future health care spending and improve the quality of care. (Source: NEJM, Feb.3,2010)

Growing Application of Pharmacoeconomics and

Growing Application of Pharmacoeconomics and Outcomes Research in Health-Care Decision-Making in the Asia-Pacific Region. (Source: Bong-min Yang, PhD, and Kenneth Lee, PhD, Values in Health, Vol. 12, 2009)

Has the influence of managed care waned? Evidence from the market for physician services

Based on data from the Community Tracking Study, the authors found that MCOs were becoming less restrictive over time in terms of limiting provider services, and were more like non-managed care organizations. (Source: International Journal of Health Care Finance and Economics, March 2010)

Health Reform’s CER “Reality Check”

Comparative Effectiveness Research (CER) has been a primary topic of both discussion and legislative debate for the past four Congressional sessions, with both House and Senate resolutions and bills drafted, debated, amended, and ultimately tabled as members tried to arrive at a meaningful way to cultivate the CER-derived evidence base within the U.S.

Healthcare Debate - The Economist

This house believes that the widespread use of comparative effectiveness reviews and cost/benefit analyses will stifle medical innovation and lead to an unacceptable rationing of health care. (Source: The Economist, October 2009)

Healthcare Rationing by Proxy: Cost-Effectiveness Analysis and the Misuse of the $50 000 Threshold in the US

Authors advocate $US 50,000 per QALY benchmark for determining value for money should be updated, and must vary across payers, populations and even procedures. (Source: PharmacoEconomics: 1 March 2010 - Volume 28 - Issue 3 - pp 175-184)

I n n ova t i ve Pricing Ag reements to Enhance Access Pro s p e c t s

REPRODUCED FROM IMS PHARMA PRICING & REIMBURSEMENT, AUGUST 2009. There is clearly an increasing need for more innovative pricing and reimbursement agreements to help to balance the often conflicting objectives of pharmaceutical and medical technology manufacturers, payers, health technology assessors (HTA), physicians and patients. The industry faces a sustained increase in the cost of healthcare and an ever-increasing range of expensive drugs and technologies available as potential therapies. Clearly, difficult choices need to be made by payers and HTAs about which products receive funding from increasingly restricted healthcare budgets, especially with often insufficient clinical and real-life evidence available. In terms of innovative agreements, more manufacturers, in more countries, are proposing risk-sharing and value-based schemes more often.

Increase Reimbursement Success by Understanding When, What, and How to Effectively Communicate with Payers

Manufacturers invest heavily into the development of products that deliver more effective treatment and many invest in the development and communication of a payer value proposition during the launch phase. (Source: Webinar, Xcenda, March 25, 2010)

Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform

This article presents the idea the further investment in and analysis of comparative effectiveness is required for health care reform. (Source: Harry P. Selker, M.D., M.S.P.H., and Alastair J.J. Wood, M.D., NEJM, Nov. 18, 2009)

Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform

Comprehensive health care should reduce the use of ineffective and suboptimal medical interventions and investigations in order to improve medical care and reduce wasted expense. To do that effectively, we need data on the comparative effectiveness of therapies and medical tests, which unfortunately we currently lack. (Source: NEJM, Nov. 18, 2009)

Innovative Pricing Agreements to Enhance Access Prospects

This PDF summarizes a 2009 Brussels Conference on these types of pricing schemes (eg, Price/Volume, Expenditure Caps, Price Cuts, Conditional Discounts), with emphasis on Europe. Contains nice table with examples of schemes by drug/country. (Source: IMS Pharma Pricing and Reimbursement, August 2009)

Innovative Pricing Agreements, Risk Sharing, Market Access Agreements

Institute for Clinical and Economic Review

Through a unique collaboration with patients, clinicians, manufacturers, insurers and other healthcare stakeholders, the Institute for Clinical and Economic Review (ICER) develops tools to support patient decisions and medical policy that share the goal of achieving maximum value for every healthcare dollar.

International survey on willingness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness? by Shiroiwa et al.

Is “Value-Based” Value Wasted? Examining Value-Based

Commentary in JMCP March 2010 issue discussing most of the recent evidence from controlled studies suggests that chronic disease management is not delivering on the promise of lowered costs through improved population health.

Is value-based pricing an aid to market access?

Leela Barham explores whether pharma firms can use value-based pricing (VBP) to improve market access.

ISPOR: PHARMACOECONOMICS: Identifying the Issues

This paper summarizes the results of an interdisciplinary conference to identify the issues in conducting pharmacoeconomic studies, interpreting the results of these studies, and using pharmacoeconomic information in health care decisions. (Source: Advisory Board & Marilyn Dix Smith PhD, ISPOR, 1998)

It's Time to Embrace Evidence-Based Medicine

This short article helps to define and explore EBM. (Source: Andrew Mcafee, HBR, Nov. 2009)

January 2010 Newsletter and Eisenberg Conference Series 2009 Are Now Available

Keeping the Patient in the Equation — Humanism and Health Care Reform

This article addresses the influence of growing interest in humanism and comparative effectiveness on health care reform. (Source: Pamela Hartzband, M.D., and Jerome Groopman, M.D, NEJM, Aug. 5, 2009)

Lost in Transmission — FDA Drug Information That Never Reaches Clinicians

Article is critical about the dissemination of information for comparative effectiveness. (Source: Lisa M. Schwartz, M.D., and Steven Woloshin, M.D., NEJM, Oct 2009)

Map of Medicine Uses Evidence-Based Medicine to Help Physicians

Map of Medicine Uses Evidence-Based Medicine to Help Physicians with care pathways, with major focus on the role of pathology and laboratory results in diagnosis. (Source: Dark Daily, Nov. 16, 2009)

Market Access EU Presentation, by Janice Haigh

This is a presentation by Janice Haigh at Market Access Europe 2010 that took place March 2-3, 2010.

MedPAC Focus Group Findings on Comparative Effectiveness: Physician Perspective, by MedPAC

Comparative effectiveness research has become a pivotal term in Washington these days, particularly after the federal government passed the American Recovery and Reinvestment Act of 2009, which authorized $1.1 billion for comparative effectiveness research. Now an analysis of findings (17-page PDF; About PDFs) from six focus groups commissioned by the Medicare Payment Advisory Commission, or MedPAC, finds that although physicians think comparative effectiveness research studies are a good idea, their support for such studies depends on a number of factors.

Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews

The Methods Guide for Comparative Effectiveness Reviews intends to improve the transparency, consistency, and scientific rigor of this work, which consists of systematic reviews of existing research on effectiveness, comparative effectiveness, and comparative harm of different health care interventions. (Source: Agency for Healthcare Research and Quality. Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews)

MS drugs scheme fails to deliver results

A pioneering scheme designed by government to impose a money-back guarantee on pharmaceutical companies if their drugs did not adequately treat patients has failed to provide any clear conclusions more than seven years after it was launched. (Source: The Health Economics Blog / The Financial Times, Dec. 4, 2009)

New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling

New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling. (Source: Stafford, Wagner, and Lavori, NEJM, Aug. 12, 2009)

NICE Outlines Appeals Process for Drug Determinations

Drugmakers appealing a final appraisal determination will be allowed to use three basic arguments, including unfair action by the institute. (Source: FDAnews Drug Daily Bulletin, Feb. 3, 2010)

NICE Stats Spur Controversy and Back Patting

With several drugs exceeding predicted use and several used less than predicted, the annual report which shows how NICE approval has affected medicine uptake in the UK has received mixed reviews. (Source: Sarah Houlton, PharmExecBlog.com, September 23, 2009)

NICE: 10 years still growing and still controversial

The National Institute for Health and Clinical Excellence (NICE) will have existed for 10 years on April 1, 2009.(Source: The Lancet Oncology, Volume 10, Issue 4, Pages 417 - 424, April 2009)

Observational Research Findings and Trends from Survey #3

Research findings from PharmaNet's 3rd survey on Observational Research. The survey continues to enjoy widespread industry support, reflecting strong interest in the topic and the fundamental need for better data on “real world” outcomes. This version of the survey explored a number of provocative topics and examined trends over time. Although there remain a number of issues that merit ongoing and open discussion, there is progress in the field.

Premera to Contribute Market Data, Experience to Seattle-Based Federal Stimulus Funded Research

Four important projects are being backed by approximately $16 million in federal stimulus funding for comparative-effectiveness research in cancer. Premera Blue Cross is taking an important role in one of the four studies, which will evaluate the effectiveness of cancer diagnostics. (Source: Premera Blue Cross, BusinessWire, October 2009)

Quantifying Disease Management Return-on-Investment: Trends,Metrics, Evaluations, Transparency and Reality

This 50-page special report contains insider information from three leading experts in DM analytics. They review key principles in calculating ROI, how to establish metrics for evaluating DM programs, and common mistakes in measuring ROI. They also share some relevant case studies for comparison.There is a fee to order this report.

Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change

Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change. (Source: Various authors, Annals of Internal Medicine, Aug. 4, 2009)

Role of Evidence-Based Medicine in Informing Clinical Decision-Making Addressed by American College of Physicians in House Testimony

This article provides a summary of testimony that Donna Sweet, MD, MACP provided on Dec 2, 2009 to the Subcommittee on Health of the House Energy and Commerce Committee. She addresses the recent breast cancer screening guidlines. (Source: ACP - American College of Physicians, Dec. 2009)

Selecting Observational Studies for Comparing Medical Interventions: New Chapter from the Effective Health Care Program Methods Guide for Comparative Effectiveness Reviews

The Agency for Health Care Research and Quality (AHRQ) Effective Health Care Program announces the release of a new chapter for the Methods Guide for Effectiveness and Comparative Effectiveness Reviews. This new chapter, “Selecting Observational Studies for Comparing Medical Interventions” is now available on the EHC Program Web site

Selecting Quality and Resource Use Measures A Decision Guide for Community Quality Collaboratives

Selecting quality of care and resource use measures is an important and challenging task for organizations striving to improve the quality of health care in their communities. This Decision Guide is designed to inform readers about the most critical issues to consider when selecting and adopting such performance measures.

Take the lead on late-phase studies, urges Quintiles executive

Pharma Co's must "get a grip" on late-phase research, or other groups (e.g., payers, FDA) will do it for you, and decisions will be based on price! The article cites the recent head-to-head clinical trial of the blood thinners Plavix (clopidogrel, Bristol-Myers Squibb/Sanofi Aventis) and Effient (prasugrel, Eli Lilly/Daiichi Sankyo) conducted by Medco. (Source: PharmaTimes, Dec. 9, 2009)

The AMCP Format for Formulary Submissions

A Format for Submission of Clinical and Economic Evidence of Pharmaceuticals in Support of Formulary Consideration.FMCP Format Executive Committee. (Source: Journal of Managed Care Pharmacy, Jan. 2010)

The AMCP Format for Formulary Submissions, Version 3.0

A Format for Submission of Clinical and Economic Evidence of Pharmaceuticals in Support of Formulary Consideration FMCP Format Executive Committee

The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health

The European Medicines Agency has launched a three-month public consultation on its draft of The Road Map to 2015: The Agency's Contribution to Science, Medicines, Health with comments due by April 30, 2010. (Source: European Medicines Agency, Jan. 2010)

The Growing Importance of Health Technology Assessments (HTAs) in

There are now over 40 national agencies globally, each with its own standards and procedures for HTA evaluation, but evaluation methods vary and are continuously changing. In order to understand the landscape for HTAs across the world, United BioSource Corporation (UBC) conducted a review of HTA requirements in 10 markets. (Source: United BioSource Corporation Evidence Matters Newsletter, March 2010).

The impact of value mining on market access

Peter Mansell explains how multiple stakeholders are analyzing data to make their own determinations of medicine value.

The Pharmacoeconomics Outlook: Turning value-for-money requirements into a competitive advantage (PPT Presentation)

Basic overview, regulatory issues, case studies on valuation, including NICE. (Source: Business Insights, 2003)

The Trials and Tribulations of Evidence Based Medicine

In an era of 'patient choice', the public should realise that they have less choice than ever before, now with protocols, guidelines and targets, many of which have financial incentives attached - choice is no longer an option.

VALUE 1000 – A PRACTICAL PROPOSAL FOR MEASURING QUALITY IN HEALTHCARE

VALUE 1000 – A PRACTICAL PROPOSAL FOR MEASURING QUALITY IN HEALTHCARE: This paper explores some practical ways of measuring quality and value in healthcare. (Source: Kishore Somanathan, Meta Analytics LLC, 2009)

Value-Based Purchasing and Comparative Effectiveness Research:

Value-Based Purchasing and Comparative Effectiveness Research: Why the Pharmaceutical, Biotechnology, and Medical-Surgical Device Industries Should Embrace the Coming Market Evolution. (Source: MarCom Group International, Inc.)

Value-Based Purchasing and Comparative Effectiveness Research:

Effectiveness Research: Why the Pharmaceutical, Biotechnology, and Medical-Surgical Device Industries Should Embrace the Coming Market Evolution. (Source: Josh Feldstein & Elizabeth Brooks, MarCom Group International, Inc.)

Webcast: Payer Value Propositions in a More Constricted, Cost-controlled Environment

Xcenda's Managed Markets consultants will discuss how manufacturers are revamping their approach to managed care messaging to increase their products' market opportunity. Key points for their presentation include impact of payer environment, building value props throughout the life cycle, and communicating this message with respect to FDAMA Sect. 114. (Source: Xcenda, April 20, 2010)

When Doctors Create Their Own Evidence-Based Medicine

The argument against evidence-based care says that no two patients are alike, so doctors must be flexible in their use of evidence and can't be bound by rigid protocols based on large studies. But Intermountain Healthcare, a network of hospitals and clinics in Utah and Idaho, has been pushing for more evidence-based care at its facilities for a while now, with some pretty interesting results. (Source: WSJ -- Health Blog, Nov. 5, 2009)

White Paper: An Economic Assessment of the Relationship between Price Regulation and Incentives to Innovate in the Pharmaceutical Industry

In this paper, we explore the possible consequences that pricing and reimbursement regulation may have on pharmaceutical innovation. We first investigate qualitatively how a pharmaceutical firm is likely to strategically respond in its R&D activities to pricing and reimbursement regulation. We then quantitatively evaluate these effects in the context of a calibrated decision-theoretic model of drug development in which a pharmaceutical firm is forward-looking and takes future pricing regulation into account in making current development decisions. Source: Hans Friederiszick, ESMT CA Nicola Tosini, ESMT CA Francis de Ve´ricourt, ESMT Simon Wakeman, ESMT

Why should economic evaluations of medical innovations have a societal perspective?

Why should economic evaluations of medical innovations have a societal perspective? (Source: Prof Magnus Johannesson, Prof Bengt Jönsson, Linus Jönsson, Gisela Kobelt, Niklas Zethraeus, Office of Health Economics, Oct 2009)

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